RE:FDA's BREAKTHROUGH DESIGNATION - COULD RVX-208 QUALIFY?
Yep. This could help. It's a bit new though so it's just now being tested. Nobody really knows how this will be interpreted except on a case by case basis. From my understanding, it typically applies to therapies that have life saving impacts for conditions which currently do not have any significant options. You could certainly make the case for 208 falling into this category.
However, from my understanding it is also primarily designed for companies with strong phase I data to go right to PIII. I'm not sure this would be much of a benefit to RVX though as they really need to conduct their 2c trial to duplicate mace numbers. I would rather see mgt focusing on raising the money for this trial versus trying to put the data package together to lobby the fda for this designation. I think the extra dilution to fund a Piii trial right now is not worth it. Duplicate Mace, and the stock will rally.